HONG KONG and SHANGHAI and FLORHAM PARK, N.J. — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration (“NMPA”) for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma (“ICC”) with fibroblast growth factor receptor (“FGFR”) 2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®.
ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.1 Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.2,3
The approval is supported by data from the Phase II registration cohort of the single-arm, multi-center, open-label, pivotal Phase II/IIIb clinical trial of ATLED® in China (NCT04353375). The results were recently presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress 2026. The study met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated advanced ICC patients harboring FGFR2-fusions/rearrangements, representing a strong, clinically meaningful response.
Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).
“As a major and devastating subtype of primary liver cancer, intrahepatic cholangiocarcinoma carries an immense disease burden with historically limited targeted options. We are thrilled by the NMPA approval of ATLED®, which directly addresses this critical therapeutic gap in China,” said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. “This approval unlocks an important new treatment alternative for a substantial population of pretreated advanced ICC patients. We are fully prepared to leverage our established commercial infrastructure to bring this precision medicine to patients as rapidly as possible.”
The Phase IIIb portion of the trial will serve as the confirmatory study to further validate the clinical benefits and safety of ATLED® in this setting. Enrollment for this confirmatory cohort was initiated in January 2026.
About ATLED®
ATLED® (fanregratinib, HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first four medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Medical Information
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References
| 1 | Expert consensus on precision detection of intrahepatic cholangiocarcinoma (2024 edition). Chin J Clin Med. 2025;32(1):1-18. |
| 2 | Arai Y, Totoki Y, Hosoda F, et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology. 2014;59:1427–34. |
| 3 | Nakamura H, Arai Y, Totoki Y, et al. Genomic spectra of biliary tract cancer. Nat Genet. 2015;47:1003–10. |